Clinical research studies are regulated, following rules set by health authorities. The clinical
research study will follow a protocol, which is a detailed study plan explaining what researchers
will do during the study. Each clinical research study must also be reviewed by an institutional review
board (IRB) or ethics committee (EC). IRBs and ECs are groups of people who help protect the rights and
welfare of people participation in research studies. IRBs and ECs are usually made up of doctors, scientists,
religious representatives, and other medical and nonmedical people. Your privacy will also be protected.
The research team cannot tell anyone that you are participating in a clinical research study without your
permission. All of the information collected during the study will be kept confidential, and your name
won't be listed in any report based on the study.